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Northwest Biotherapeutics, Inc. Message Board

  • nakamuraakiko nakamuraakiko Sep 17, 2013 8:30 AM Flag

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    Unfortunately, the most important question affecting at least NWBO's near/intermediate future went unanswered during the conversation with Les Goldman. This of course pertains to the degree of efficacy to be shown from the human trials of DC direct Vax. Since Les confirmed that no compassionate use human trials had been performed prior to the initiation of the clinical human trials, the decision to go forward was based upon the pre-clinical mouse studies which were highly successful. Heretofore, even remarkable oncological animal trial results were not carried over to the human trials which have been rather disappointing. The difference between such previous animal pre-clinicals and the NWBO mouse studies is the claim that the mice were genetically altered such that the disease environment and the immune response etiology more closely mimicked the human environment. Accordingly, and presumably, the predictive value of such animal tests begets greater confidence that the results seen there can be carried over in meaningful measure to the human trials. However, without clearly understanding the mouse genetic alteration environment and how closely it mimics the human condition, it is difficult to assess its predictive value wrt human trials. What was it exactly that impelled MD Anderson to approach NWBO to become a lead facility in conducting the human trials? This has not been revealed. Presumably, MD Anderson would not have gone forward with such testing unless it was fairly well convinced of the science and its mechanism of action(MOA) and the value of the pre-clinical mouse studies. MD Anderson had been known as strongly favoring chemo and radiation therapies and highly skeptical of alternate immunotherapy approaches. One would think that this institution is very careful wrt novel therapies so as not to subject its patients to hopeless and ineffective palliatives and life extending procedures. It also has its reputation as a top cancer research center to uphold.

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    • First, why do you think MD Anderson approached NWBO? A few people have said this but I'm not buying it.

      Also, going ahead with Direct was very risky considering " that no compassionate use human trials had been performed". Think they have a hard time getting funding now, if direct fails no one will give them money for "L" and will be done.

      So my guess is they either know "direct" has worked in humans but are unable to say anything about it which is why they went ahead with the direct trial and was able to get MD Anderson on board, or they are completely insane not thinking negative Direct results will kill off the company completely.

      Time will tell soon enough.

      • 1 Reply to nowwhat654
      • what a strange post.
        they are not completly mad.
        people who fund NWBO want the money to be spent on the science , that is what thye are doing.
        th e trail wont be that expensive anyway.
        if you dont like the risk move on.
        you dont get anywhere if you dont take risks and go out there and treat people.
        go and buy apple shares.
        its a phase one trail.
        good on nwbo for having the guts to try and see if it works on humans.
        how else will we move forward and try and help these poor people with cancer who are
        simply sent home to die.

 
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